MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. AIRLIFE¿; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 002450

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

During daily albuterol/pentamidine treatment on post transplant patient the meds are getting through the middle filter on device/tubing and pooling.It is difficult to determine how much med the patient received.We recommend to hold the device upright to avoid getting med in mouth or on floor but with lot #0004147582 we have had multiple issues with med leaking.

• Brand Name: AIRLIFE¿
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 14117326
• MDR Text Key: 289329408
• Report Number: 14117326
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 002450
• Device Catalogue Number: 002450
• Device Lot Number: 0004147582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9855 DA
• Patient Sex: Female